Discussion of concerns over heritable human genetic modification has spiked in 2015.

This dialogue is a good thing, but is it in a sense too late?

Are genetically modified (GM) people a foregone conclusion?

Rumors are swirling that upwards of four papers reporting production of GM human embryos are in various stages of review at high-profile journals, sparking a sense of urgency for some kind of steps to deal with this new reality. Could these papers report germline correction of the CTFR mutation in cystic fibrosis or of a BRCA1 mutation? Were these GM human embryos used to make embryonic stem cell lines or are they cryopreserved?

The prime concern now is that GM human embryos could in principle be rather simply turned into GM humans at any one of thousands of IVF clinics around the world with a surrogate mother. That simple technological step of going from GM human embryo to GM human being of course invokes incredibly complicated, thorny legal, bioethical and societal issues.

So stakeholders have been weighing in recently on anticipating how to deal with this evolving situation.

Lanphier, et al. in Naturerecentlymade the case in a piece called “Don’t edit the human germline” that GM human embryos should not be produced. Baltimore, et al. argued in Science for increased dialogue, but stopped short of proposing any kind of moratorium. ISSCR called for a moratorium on attempts at clinical applications of human nuclear germline modification.

My own take on this has been a more practical, specific approach that I call the ABCD planthat draws a bright line between allowable in vitro work (under very specific, mandatory rules, training, transparency, and oversight) and in vivo applications.

As this positive dialogue has proceeded, there is a troubling backstory. The sense I’ve gotten from some of those in the know is that there are researchers already intent upon going ahead to make GM human beings. Some believe it is not a question of if, but rather when and under what circumstances.

Interestingly, while there has been talk that from a legal and regulatory perspective that such an endeavor would “not be allowed” currently, I’m not so sure.

For example, here in the US if a GM baby was made, what could anyone do after the fact? Would the FDA really take some kind of punitive action and wouldn’t it be too little too late anyway? What about in China? I’ve heard people say there are regulations against making GM humans in China, but would they be effective?

If it is not too late to stop the production of GM people at this time, are there things we could be doing now besides increased dialogue to chart a safer path forward? If so, my sense is that time is short.

I think the best we can hope for here from these rumored papers is that the edited embryos were then used to make ES cells. That or that these embryos were going to be discarded anyway. Still not the best ethically, perhaps, but better than the alternative to me, anyway.

At the very least, maybe the sequence analysis and the validation will be interesting.